Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| King's College London | OTHER |
Not provided
Not provided
Not provided
Not provided
This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after repeated doses in patients with stable but symptomatic schizophrenia, taking one or two established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition and tests of auditory function and electrophysiological measures in addition to routine safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a key objective is to characterize this range of biomarkers which will inform the future development of the drug.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose AUT00206 800 mg BD | Experimental | AUT00206 800mg twice daily for 28 days |
|
| Placebo | Placebo Comparator | Placebo to match AUT00206 twice daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AUT00206 | Drug | 4 capsules of 200mg AUT00206, twice daily, to take orally with food for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo | 28 days | |
| Plasma concentrations of AUT00206 | 28 days |
Not provided
Not provided
Key inclusion Criteria:
Key exclusion Criteria:
Male 18-50 Years
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London Institute of Psychiatry, Psychology and Neuroscience (IoPPN) | London | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 4 capsules of placebo, twice daily, to take orally with food for 4 weeks |
|
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided